Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID b5b6fb87-7c02-4b8a-b185-2a53678b49d2

Route

NASAL

Published

Effective Date 2012-11-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Oxymetazoline (0.05 g)

Inactive Ingredients

Benzalkonium Chloride Benzyl Alcohol Edetate Disodium Polyethylene Glycols Povidone Propylene Glycol Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-10-26

Description

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Oxymetazoline HCl 0.05%

Uses

temporarily relieves nasal congestion due to:

common cold
hay fever
upper respiratory allergies
sinusitis

reduces swelling of nasal passages; shrinks swollen membranes
temporarily restores freer breathing through the nose

Warnings

Do not use this product for more than 3 days

Directions

To spray, squeeze bottle qiuckly and firmly
Do not tilt head backward while spraying
Wipe nozzle clean after use
Do not exceed 2 doses in any 24 hour period
adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours
chlidren under 6 years of age: ask a doctor

Carton Image

Active Ingredient

Oxymetazoline HCl 0.05%

Other Information

store at room temperature 15° - 30°C (59°-86°F)

retain carton for future reference on full labeling

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

When Using This Product

do not exceed recommended dosage
use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen
temporary discomfort such as burning, stinging, or an increase in nasal discharge may occur
use of this container by more than one person may spread infection

Stop Use and Ask A Doctor If

symptoms persist

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate

Structured Label Content

Uses

temporarily relieves nasal congestion due to:

common cold
hay fever
upper respiratory allergies
sinusitis

reduces swelling of nasal passages; shrinks swollen membranes
temporarily restores freer breathing through the nose

Purpose

Nasal decongestant

Warnings

Do not use this product for more than 3 days

Directions

To spray, squeeze bottle qiuckly and firmly
Do not tilt head backward while spraying
Wipe nozzle clean after use
Do not exceed 2 doses in any 24 hour period
adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours
chlidren under 6 years of age: ask a doctor

Carton Image (Carton image)

Active Ingredient (Active ingredient)

Oxymetazoline HCl 0.05%

Other Information (Other information)

store at room temperature 15° - 30°C (59°-86°F)

retain carton for future reference on full labeling

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

When Using This Product (When using this product)

do not exceed recommended dosage
use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen
temporary discomfort such as burning, stinging, or an increase in nasal discharge may occur
use of this container by more than one person may spread infection

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms persist

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate

Advanced Ingredient Data

[{"name": "OXYMETAZOLINE", "unii": "8VLN5B44ZY", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOLS", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies sinusitis reduces swelling of nasal passages; shrinks swollen membranes temporarily restores freer breathing through the nose", "Purpose": "Nasal decongestant", "Warnings": "Do not use this product for more than 3 days", "Directions": "To spray, squeeze bottle qiuckly and firmly Do not tilt head backward while spraying Wipe nozzle clean after use Do not exceed 2 doses in any 24 hour period adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours chlidren under 6 years of age: ask a doctor", "Active ingredient": "Oxymetazoline HCl 0.05%", "Other information": "store at room temperature 15° - 30°C (59°-86°F) retain carton for future reference on full labeling", "Inactive ingredients": "benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water", "When using this product": "do not exceed recommended dosage use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen temporary discomfort such as burning, stinging, or an increase in nasal discharge may occur use of this container by more than one person may spread infection", "Stop use and ask a doctor if": "symptoms persist", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:34.789243 · Updated: 2026-03-14T22:53:23.299879